B. Braun

Sr. Supplier Quality Engineer

US-PA-Breinigsville
Requisition ID
2018-11560
Company
Aesculap Implant Systems
# of Openings
1
Category
Quality
Position Type
Regular Full-Time
Shift
8 am to 5 pm
Site
Aesculap Implant Systems

Overview

Aesculap Implant Systems, LLC, a B. Braun company, is part of a 180-year-old global organization focused on meeting the needs of the changing healthcare environment. Through close collaboration with its customers, Aesculap Implant Systems develops advanced spine and orthopaedic implant technologies to treat complex disorders of the spine, hip and knee. Aesculap Implant Systems strives to deliver products and services that improve the quality of patients’ lives.

 

 

 

 

Responsibilities

Position Summary:

 

Provide quality management for Aesculap external and internal suppliers; monitor the quality parameters of the assigned suppliers, assist with validations and report performance on a regular basis. Works with St. Louis Operations, Supply Chain, TekPark R&D Engineering, Aesculap AG and Product Management Teams, to proactively lead quality initiatives with suppliers including identifying and implementing improvements regarding their quality, performance and cost.

Responsibilities: Essential Duties

  • Works directly with Aesculap Supply Chain to develop and control suppliers.
  • Lead change management, SCARs and escalations for suppliers.
  • Participate in compliance issues, recalls, and field actions that are related to suppliers.
  • Champion selection and qualification of new suppliers in cooperation with other departments.
  • Creates test plans for incoming, in process and final inspection.
  • Assess the impact of reported quality changes on the status of the suppliers, materials and coordinate the required corrective actions as needed. 
  • Lead proactive quality initiatives with suppliers to identify and implement improvements regarding their quality, performance, and cost.
  • Establish and handle periodic review of supplier quality file with regards to supplier assessments and Quality Agreements.
  • Works with suppliers on Quality Agreements.
  • Creates process and equipment validations for internal suppliers
  • Assists on supplier process and equipment validations.
  • Performs Risk Analyses per ISO14971 on hazards to inspection, production, and design
  • Reviews Supplier Evaluations and performs assessments.
  • Works Quality System documents to support ISO13485.
  • Must comply with applicable ISO and FDA regulations as stated in Quality Manual.
  • Must embody the Company’s Vision, Mission and Values.
  • Other duties may be assigned.

Secondary or peripheral job functions:

  • Must be able to travel by air and car, and work occasional weekends.
  • Requires excellent written and interpersonal communication skills.
  • This position requires the handling of instruments that may have been contaminated by blood or other bodily fluids. In compliance with Occupational Safety and Health Administration (OSHA) regulations, Aesculap will provide a safe working environment for all employees.  
  • Uses professional concepts in accordance with company objectives to help solve complex problems in creative and effective ways, complete projects as assigned and achieve goals.
  • Coordinates and supports team activities using creative thinking and organizational skills.
  • Works well with limited supervision.

Expertise: Knowledge & Skills

  • Language Skills: Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to effectively present information to top management, public groups, and/or boards of directors.  
  • Mathematical Skills: Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
  • Reasoning Ability: Ability to define problems, collect date, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Qualifications

Expertise: Qualifications-Experience/Training/Education/Etc

 

Required:

  • BS in Engineering, Life Science, Mathematics or equivalent required. Master’s degree in Engineering or Life Science preferred.
  • 5-7 years experience in Medical Device Supplier Quality with BS/BA or 3 years with MS/MA required.
  • Must have 5 years of auditing experience (can include either internal or external auditing); External auditing experience is preferred.
  • CQA (Certified Quality Auditor) or other equivalent certification required.
  • A minimum of 7 years of relevant experience in medical device or regulated industry is required.
  • Strong knowledge of Change Control, Deviation Handling, Production/Process controls, and SCAR is required.
  • Process validation documentation creation experience required.
  • Must have strong Quality and Compliance experience in FDA regulated industry.
  • Must have understanding of FDA GMPs, ISO13485, and ISO14971

Desired:

  • N/A

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.

 

 

 

Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com Equal Opportunity Employer Minorities /Women/ Veterans/Disabled.

Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. 

Other

Responsibilities: Other Duties:


 The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.

 Physical Demands:

 The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Work Environment:

  • This position could require the handling of instruments that may or may not have been contaminated by blood or other body fluids. In compliance with Occupational Safety and Health Administration (OSHA) regulations, Aesculap will provide a safe working environment for all employees.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.

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